NCT05251298

Brief Summary

The purpose of this study is to evaluate the efficacy of an online platform that allows neurologists and therapists to exchange therapy recommendations, communicate assessments and plan physical therapy, occupational therapy as well as speech and swallowing therapy for their patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

December 9, 2021

Last Update Submit

April 18, 2023

Conditions

Parkinson Disease

Keywords

Activities of Daily LivingDisease ManagementQuality of LifeRehabilitationPatient-Centered CareDelivery of Health CareIntegrated Care

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life measured by PDQ 39

    The Parkinson's Disease Questionnaire (PDQ-39, max. score of 100 indicates the worst quality of life)

    Change from Baseline PDQ 39 at 12 months

Secondary Outcomes (4)

  • Change in Health-related resource use in the elderly population, assessed by FIMA

    Change from Baseline FIMA at 12 months

  • Change in disease severity measured by UPDRS

    Change from Baseline UPDRS at 12 months

  • Change in disease severity measured by Hoehn & Yahr

    Change from Baseline UPDRS at 12 months

  • Change in mobility, measured by Schwab- & England-Scale

    Change from Baseline Schwab-&England-Scale at 12 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.

Other: Coordination through the online platform "JamesAKTIV"

Control group

NO INTERVENTION

Patients in the control group will undergo their usual therapies as prescribed by their neurologists.

Interventions

Coordination through the online platform "JamesAKTIV"OTHER

Coordination of the treatment through the online platform "JamesAKTIV" that allows neurologists and therapists to select specialised therapies for the predominant symptoms of the patients and communicate easily about problems during the treatment

Intervention group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's Disease with pharmacological treatment
  • years old or older
  • place of residence: Münsterland, Tecklenburger Land, Kreis and Stadt Osnabrück
  • sufficient knowledge of the German language, should be able to understand the consent form

You may not qualify if:

  • severe cognitive deficits
  • Atypical Parkinsonian Disorders
  • participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Münster, Klinik für Neurologie

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Related Publications (1)

  • Achtert K, Huchtemann T, Altendorf M, Kerkemeyer L, Haring M, Lummer C, Frenz L, Becking T, Friedmann J, Mildner P, Schwarze K, Steinhaus L, Amelung V, Warnecke T. Design and implementation of ParkinsonAKTIV: an interventional study to evaluate the effectiveness of a novel online platform to guide quickcard-based treatment decisions. Neurol Res Pract. 2023 Jun 1;5(1):23. doi: 10.1186/s42466-023-00249-5.

    PMID: 37259124DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Tessa Huchtemann, Medical Degree

CONTACT

004915254956565Tessa.Huchtemann@ukmuenster.de

Tobias Warnecke, Medical Degree, PhD

CONTACT

00492518345314Tobias.Warnecke@ukmuenster.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Tobias Warnecke

Study Record Dates

First Submitted

December 9, 2021

First Posted

February 22, 2022

Study Start

November 28, 2021

Primary Completion

March 1, 2024

Study Completion

October 1, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)